Eye Drop Dispensing Device With Segmented Containers

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Solution Overview

Problem

Existing eye drop dispensing devices are complex and fail to ensure optimal separation of substances, leading to incorrect solution preparation if mixing occurs at the wrong moment.

Innovation Solution

A compact, simple, and reliable eye drop dispensing device is designed with a first container for water and a second container for a freeze-dried therapeutic agent, where the containers are sterilized and assembled in a fluid-tight manner, allowing for controlled mixing and preparation of a multidose eye solution using a dispensing member.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If known devices are used to contain two different substances, then the substances can be stored separately, but the separation is not optimal and mixing may occur at the wrong moment

Engineering Contradiction:
Improveseparation of substancesVSAvoidcomplexity of keeping substances separate
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into two separate containers (first container for water, second container for freeze-dried substance) that are assembled together. This segmentation allows independent storage and controlled mixing, solving the problem of unreliable separation in known devices.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The first container is nested inside the second container, with the first container positioned within the seat defined by the second container's wall. This nested configuration ensures optimal separation while maintaining a compact structure and preventing premature mixing.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If a compact and simple device is designed, then ease of manufacture and operation improve, but the ability to ensure optimal separation and controlled mixing may be compromised

Engineering Contradiction:
Improvesimplicity of deviceVSAvoidcontrolled mixing capability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The containers are pre-sterilized and the freeze-dried substance is prepared in advance in the second container. This preliminary action ensures that when the device is assembled and used, the mixing process is already optimized and controlled, maintaining reliability while keeping the device simple.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The seat structure acts as an intermediary between the two containers, providing a controlled interface that allows separation when needed and controlled mixing when required. This intermediary structure simplifies the device while ensuring reliable controlled mixing.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If sterilization steps are added to the manufacturing process, then product reliability and sterility improve, but manufacturing complexity and time increase

Engineering Contradiction:
Improvesterility of deviceVSAvoidmanufacturing speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The first and second containers are sterilized in advance during the manufacturing process, before assembly. This preliminary sterilization action ensures product reliability and sterility are achieved without adding complex sterilization steps during assembly or use, maintaining manufacturing efficiency.

Inventive Principle:
Principle #10Preliminary action

4Duration of action of stationary object

If freeze-drying is used to preserve the therapeutic agent, then stability and shelf life improve, but the manufacturing process complexity increases

Engineering Contradiction:
Improveshelf life of therapeutic agentVSAvoidmanufacturing process complexity
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The therapeutic agent is converted to a freeze-dried state (phase transition from liquid to solid through freezing and sublimation) for long-term storage. This phase transition allows the agent to be stored stably at room temperature and reconstituted when needed, extending shelf life while using a well-established manufacturing process.

Inventive Principle:
Principle #36Phase transitions

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The device ensures a compact, ergonomic, and automated process for preparing a stable multidose eye solution, maintaining sterility and allowing for prolonged use, up to 90 days, with simplified and cost-effective production.

Implementation Method 1

the step of subjecting the first container/second container/spacer assembly to a freeze-drying atmosphere so as to cause the outflow of an aqueous content of the solution or dispersion comprising the drug from the opening (14) of the collar (13), obtaining a freeze-dried composition (300) comprising the drug

Methodology Applied
Scientific EffectFreeze-drying: Freeze Drying

Implementation Method 2

the water or water-based solution for injection freezing without coming out of the seat (15) so that, following removal of the first container/second container/spacer assembly from the freeze-drying atmosphere, the water or water-based solution for injection becomes liquid again

Methodology Applied
Scientific EffectFreezing: Freezing

Data Source

PatentEP3280654B1Method for manufacturing a dispensing device for eye drops
Publication Date: 2020.06.10 DOMPE FARMACEUTICI SPA
  • EP3280654B1 patent drawingFigure 1~2
  • EP3280654B1 patent drawingFigure 3~5

AI summary

The present invention relates to a process for the production of a device (1 ) for dispensing eye drops. The process comprises the steps of: - providing a first container (2) and a second container (3) configured to be engaged in a fluid-tight manner, - providing a spacer (4), - introducing a water-based solution (200) inside the first container (2), - introducing a solution or dispersion comprising a drug inside the second container (3), - arranging the spacer (4) between the first and second containers (2, 3), - engaging in a fluid-tight manner the second container (3) and the first container (2); and - freeze-drying the solution or dispersion comprising the drug.